The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0376-2018·Announced 2018-02-21

Sage Q CARE Oral Cleansing System Recalled for Cross-Contamination

Sage Products Inc. is recalling Q CARE q2 Oral Cleansing & Suctioning Systems because oral care solutions were manufactured on equipment shared with non-pharmaceutical products.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential contamination or significant injury risks, even if specific hospitalization reports are not detailed in the provided text snippet.

Plain-English summary

Sage Products Inc. is recalling 5,579 cases of the Q CARE q2 Oral Cleansing & Suctioning System. The product contains a covered Yankauer, Y-connector, suction toothbrushes with Antiplaque solution, suction oral swabs with Perox-A-Mint solution and alcohol-free mouthwash, and oropharyngeal suction catheters. The affected lots are 57496, 57555, 58045, 58972, 59162, 59835, 60309, and 61188, with expiration dates ranging from August 14, 2017, to February 23, 2018.

The recall was initiated because the oral care solutions were manufactured by a third-party supplier on equipment that was shared with non-pharmaceutical products. This cross-contamination risk prompted the FDA to classify the recall as Class II.

The product was distributed nationwide in the United States and Puerto Rico, as well as in Canada, the United Kingdom, Ireland, the Netherlands, and New Zealand. Consumers and healthcare facilities should stop using the affected products and contact Sage Products Inc. for instructions on returning or disposing of the items.

The recalled product

Product
Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution, 6 Suction Oral Swab packages with Alcohol-Free mouthwash, 4 Oropharyngeal…
Manufacturer
Sage Products Inc
Category
Medical Device — Oral Care / Suctioning
Hazard
Affected units
5,579

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • Product Code: 6422
  • Lots: 57496
  • 57555
  • EXP 08/14/2017
  • 58045
  • EXP 09/11/2017
  • 58972
  • EXP 11/03/2017
  • 59162EXP 11/13/2017
  • 59835
  • EXP 01/02/2018
  • 60309
  • EXP 02/05/2018
  • 61188
  • EXP 02/23/2018

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 64 recalled by Sage Products Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 64 products in this recall →

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